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Drug Use Investigation for AVOLVE(BPH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01376284
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : July 28, 2014
Information provided by (Responsible Party):

Brief Summary:
The study is designed to investigate the safety and efficacy of dutasteride capsules 0.5 mg collected from the required number of Japanese subjects with benign prostatic hyperplasia (BPH) in order to identify concerns or problems, if any, about the efficacy and safety of its use at post-marketing clinical settings.

Condition or disease Intervention/treatment
Prostatic Hyperplasia Drug: Dutasteride

Study Type : Observational
Actual Enrollment : 1000 participants
Time Perspective: Prospective
Official Title: Drug Use Investigation for AVOLVE(BPH)
Study Start Date : December 2010
Primary Completion Date : October 2013
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Dutasteride
U.S. FDA Resources

Group/Cohort Intervention/treatment
Subjects prescribed dutasteride capsules
Subjects with BPH prescribed dutasteride capsules during study period
Drug: Dutasteride
Collection of safety data

Primary Outcome Measures :
  1. The number of adverse events in Japanese subjects with BPH treated with dutasteride capsules [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Japanese male adult subjects with benign prostatic hyperplasia (BPH) who start the treatment with dutasteride capsules

Inclusion Criteria:

  • Must be male subjects
  • Use dutasteride capsules for the first time

Exclusion Criteria:

  • Subjects who is hypersensitivity to dutasteride or 5α reductase inhibitor
  • Subjects with severe hepatic function disorder
  • Dutasteride capsules shall not be used to female or child

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376284

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01376284     History of Changes
Other Study ID Numbers: 114125
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: July 28, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs